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Quantitative detection method of acetylcysteine related substances in organ preservation solution

A technology of acetylcysteine, quantitative detection method, applied in the field of medicine

Active Publication Date: 2013-09-25
HUAREN PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0004] How to find a method that can quickly, accurately and quantitatively detect acetylcysteine-related substances in organ preservation solutions is a technical problem that plagues those skilled in the art, and it has not been solved for a long time.

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  • Quantitative detection method of acetylcysteine related substances in organ preservation solution
  • Quantitative detection method of acetylcysteine related substances in organ preservation solution
  • Quantitative detection method of acetylcysteine related substances in organ preservation solution

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Embodiment Construction

[0028] The embodiment of the method for quantitative detection of acetylcysteine-related substances in the organ preservation solution of the present invention is as follows:

[0029] (1) Determination of limits

[0030] With reference to the limit value of impurities of active ingredients allowed in the preparation, combined with its own process and product quality, the limits of related substances are determined as follows: L-cysteine ​​20 μg / ml, acetylcysteine ​​impurity C (N,N-diacetylcysteine Amino acid) 30μg / ml, acetylcysteine ​​impurity D (N,S-diacetylcysteine) 20μg / ml.

[0031] (2) Detection method and sample preparation

[0032] The detection method is HPLC detection method: according to the high performance liquid chromatography of "Chinese Pharmacopoeia" 2010 edition appendix III D, using octadecylsilane bonded silica gel as filler; flow rate: 0.8-1.2ml / min; mobile phase: containing 0.02M sodium heptanesulfonate or sodium n-pentanesulfonate, ammonium sulfate buffe...

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Abstract

The invention provides a quantitative detection method of acetylcysteine related substances in an organ preservation solution. The quantitative detection method is characterized by comprising the steps of: (1) determination of the limits of three acetylcysteine related substances in a preparation; (2) methodology validation of the detection method and determination of the acetylcysteine related substances in the preparation. The quantitative limits of the three related substances are determined by adopting an HPLC (High Performance Liquid Chromatography) detection method with reference to allowed limit values of active ingredient impurities in the preparation and an existing process of the preparation; the methodology validation is carried out on the detection method in the aspects of specificity, linearity, sample injection recovery rate, repeatability, durability and the like to prove that direct injection detection results of a stock solution of the organ preservation solution A are good. The quantitative detection method abandons an inapplicable self-control quantitative method, can be used for realizing the quantitative determination of the acetylcysteine related substances in the organ preservation solution by using an external standard method for the first time and effectively controlling the quality of the organ preservation solution, and is beneficial to the guidance of process study and the improvement of the product safety.

Description

technical field [0001] The invention belongs to the technical field of medicine, and specifically relates to a quantitative detection method for acetylcysteine-related substances in organ preservation solutions. Background technique [0002] Organ preservation solutions are generally packaged in double-chamber bags. Organ preservation solution A is in the first chamber, and the remaining components are liquid B in the second chamber. Adjacent chambers are weakly welded partitions, and the middle chamber is squeezed. The weakly welded septum is opened, so that the liquid medicine in the two chambers can be mixed evenly before use, and the preservation effect is better. In the organ preservation solution A produced by the existing technology, the content of acetylcysteine ​​decreased significantly, and the content of acetylcysteine ​​generally decreased by 2% to 3% before and after sterilization, and the higher the residual oxygen in the product, The more obvious the reductio...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
Inventor 尹冬丽叶芳刘春霞魏丹张旭东
Owner HUAREN PHARMACEUTICAL CO LTD
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